Study of IMOVAX POLIO® Subcutaneous as a Booster Vaccine in Pre-school Age Children in Japan

Sanofi

Status and phase: Completed; Phase 4

Conditions: Poliomyelitis; Polio

Treatments: Biological: IMOVAX POLIO®: Inactive Poliovirus Vaccine

Study type: Interventional

Funder types: Industry

Identifiers

NCT02005536

U1111-1143-8561 (Other Identifier)

IPV46 (EFC13614)

Details and patient eligibility

About

The aim of the study is to assess the immunogenicity of SP059 (IMOVAX POLIO®: Inactive Poliovirus Vaccine) vaccine against poliovirus and safety after fifth dose.

Primary Objective:

• To investigate the booster vaccine response rate against poliovirus types 1, 2 and 3 one month following the vaccination dose with SP059 as 2nd booster

Secondary Objectives:

• To investigate seroprotection rates (percentage of subjects presenting poliovirus neutralizing antibody titers above 1:8 (1/dil.) at pre- and post-booster time points, Geometric mean titers (GMT) at pre- and post-booster time points and geometric mean of individual titer ratio (GMTR).
• To investigate the safety after dosing of SP059 as 2nd booster.

Full description

Participants will receive one dose of SP059 (at Visit 1) as a booster vaccination at an age from 4 to 6 years. They will be assessed for immunogenicity at baseline (pre-vaccination) and at 4-6 weeks post- vaccination.

Safety data including serious adverse events (SAEs) after vaccination will be collected during the study period.

Enrollment: 60 patients

Sex: All

Ages: 4 to 6 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Aged 4 to 6 years inclusive on the day of inclusion
• Subjects who received 4 times an IPV-containing vaccine (DTaP-IPV or IPV) during first (3 doses) and second year of life (one dose)
• Informed consent form signed by the parent(s) or other legal representative
• Able to attend all scheduled visits and to comply with all trial procedures.

Exclusion criteria

• Fever ≥ 37.5°C (axillary temperature) on the day of inclusion
• Any serious disease whether acute or chronic
• Past or current medical history of Guillain-Barre syndrome, acute thrombocytopenic purpura or encephalopathy
• History of poliomyelitis infection
• History of a life threatening reaction to a vaccine containing the same substances of the study vaccine
• History of anaphylaxis or allergy to any of the study vaccine components
• Congenital or current/previous acquired immunodeficiency, immunosuppressive therapy such as long-term systemic corticosteroids therapy
• Participation in another clinical trial within 6 months before the trial inclusion
• Planned participation in another clinical trial during the present trial period
• Received oral or injected antibiotic therapy within the 72 hours prior to any blood draw
• Received antipyretics/analgesics/Non-steroidal anti-inflammatory drugs (considered as a single category) within 4 hours prior to vaccination
• Blood or blood-derived products received in the past or current or planned administration during the trial (including immunoglobulins)
• Any vaccination with live vaccines within the past 27 days preceding the trial vaccination
• Any vaccination with inactivated vaccines within the past 6 days preceding the trial vaccination
• Clinical or known serological evidence of systemic illness including Hepatitis B, Hepatitis C and/or HIV infection
• Subject ineligible according to the Investigator's clinical judgment.

Trial design

Primary purpose: Prevention

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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60 participants in 1 patient group

Study Group

Experimental group

Description:

Participants will receive one booster dose of SP059 (IMOVAX POLIO®)

Treatment:

Biological: IMOVAX POLIO®: Inactive Poliovirus Vaccine